Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis

Exclusion Criteria

• •1. Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
• •2. Known bulky central nervous system disease.
• •3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN) and direct bilirubin \> 4x ULN.
• •4. Inadequate renal function defined by serum creatinine clearance/estimated clearance of \<20(ml/min).
• •6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \< 1000 cells/mm\^3, platelet count \< 30,000 mm\^3, or hemoglobin \< 8 g/dL. Subjects with absolute lymphocyte count \< 300 cells/mm\^3 may be excluded (due to potential challenges with producing CART cells), per investigator judgement.
• •7. Echocardiogram with left ventricular ejection fraction \< 40%.
• •8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg/m\^2/d hydrocortisone or equivalent)
• •9. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.
• •10. Known human immunodeficiency virus (HIV) positive status.
• •11. Active Hepatitis B or Hepatitis C active infection.
• •12. Active CMV infection.
• •13. Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.
• •14. Chronic atrial fibrillation with uncontrolled heart rate.
• •15. Second primary malignancies that has required therapy in the last 2 years or is not in complete remission.
• •16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:
• •1. Have been on a stable dose of anticoagulation for \< 1 month (except for acute line insertion induced thrombosis.)
• •2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days
• •3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).
• •17. Pregnant or lactating women.
• •18. Participation in another interventional clinical trial within 30 days prior to screening visit.